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Elena Arellano-Orden,1,2 Carmen Calero,1,2 Cecilia López-Ramírez,1,2 Verónica Sánchez-López,1,2 José Luis López-Villalobos,1,2 María Abad Arranz,1,2 Ana Blanco-Orozco,1 Remedios Otero-Candelera,1,2 José Luis López-Campos1,21Unidad Médico-Quirúrgica de Enfermedades Respiratorias, Instituto de Biomedicina de Sevilla (IBiS), Hospital Universitario Virgen del Rocío, Universidad de Sevilla, Seville, Spain; 2CIBER de Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III, Madrid, SpainBackground: Previous studies have shown that the arterial wall is a potential source of inflammatory markers in COPD. Here, we sought to compare the expression of acute phase reactants (APRs) in COPD patients and controls both at the local (pulmonary arteries and lung parenchyma) and systemic (peripheral blood leukocytes and plasma) compartments.Methods: Consecutive patients undergoing elective surgery for suspected primary lung cancer were eligible for the study. Patients were categorized either as COPD or control group based on the spirometry results. Pulmonary arteries and lung parenchyma sections, peripheral blood leukocytes, and plasma samples were obtained from all participants. Gene expression levels of C-reactive protein (CRP) and serum amyloid A (SAA1, SAA2, and SAA4) were evaluated in tissue samples and peripheral blood leukocytes by reverse transciption-PCR. Plasma CRP and SAA protein levels were measured by enzyme-linked immunosorbent assays. Proteins were evaluated in paraffin-embedded lung tissues by immunohistochemistry.Results: A total of 40 patients with COPD and 62 controls were enrolled. We did not find significant differences in the gene expression between COPD and control group. Both CRP and SAA were overexpressed in the lung parenchyma compared with pulmonary arteries and peripheral blood leukocytes. The expression of SAA was significantly higher in the lung parenchyma than in the pulmonary artery (2-fold higher for SAA1 and SAA4, P=0.015 and P

Jose Luis Lopez-Campos,1,2 Carmen Calero-Acuña,1,2 Eduardo Márquez-Martín,1 Esther Quintana Gallego,1,2 Laura Carrasco-Hernández,1 Maria Abad Arranz,1 Francisco Ortega Ruiz1,2 1Virgen del Rocio University Hospital, Biomedicine Institute of Seville (IBiS), Hospital Universitario Virgen del Rocío, Universidad de Sevilla, Sevilla, Spain; 2Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III, Madrid, Spain Objective: The combination of a long-acting muscarinic antagonist (LAMA) and a long-acting β2-agonist (LABA) in a single inhaler is a viable treatment option for patients with chronic obstructive pulmonary disease (COPD). Here, we systematically review the current knowledge on double bronchodilation for the treatment of COPD, with a specific focus on its efficacy versus placebo and/or monotherapy bronchodilation. Methods: A systematic review of clinical trials investigating LABA/LAMA combination therapies was conducted. Articles were retrieved from PubMed, Embase, and Scopus on June 26, 2016. We specifically selected clinical trials with a randomized controlled or crossover design published in any scientific journal showing the following characteristics: 1) comparison of different LABA/LAMA combinations in a single inhaler for patients with COPD, 2) dose approved in Europe, and 3) focus on efficacy (versus placebo and/or bronchodilator monotherapy) in terms of lung function, respiratory symptoms, or exacerbations. Results: We analyzed 26 clinical trials conducted on 24,338 patients. All LABA/LAMA combinations were consistently able to improve lung function compared with both placebo and bronchodilator monotherapy. Improvements in symptoms were also consistent versus placebo, showing some lack of correlation for some clinical end points and combinations versus monotherapy bronchodilation. Albeit being an exploratory end point, exacerbations showed an improvement with LABA/LAMA combinations over placebo in some trials; however, scarce information was available in comparison with bronchodilator monotherapy in most studies. Conclusion: Our data show consistent improvements for LABA/LAMA combinations, albeit with some variability (depending on the clinical end point, the specific combination, and the comparison group). Clinicians should be aware that these are average differences. All treatments should be tailored at the individual level to optimize clinical outcomes. Keywords: COPD, bronchodilators, efficacy, systematic review

Jose Luis López-Campos,1,2 Maria Abad Arranz,1 Carmen Calero-Acuña,1,2 Fernando Romero-Valero,3 Ruth Ayerbe-García,4 Antonio Hidalgo-Molina,3 Ricardo I Aguilar-Pérez-Grovas,4 Francisco García-Gil,5 Francisco Casas-Maldonado,6 Laura Caballero-Ballesteros,5 María Sánchez-Palop,6 Dolores Pérez-Tejero,7 Alejandro Segado Soriano,7 Jose Calvo-Bonachera,8 Bárbara Hernández-Sierra,8 Adolfo Doménech,9 Macarena Arroyo-Varela,9 Francisco González-Vargas,10 Juan J Cruz-Rueda10 1Unidad Médico-Quirúrgica de Enfermedades Respiratorias, Instituto de Biomedicina de Sevilla (IBiS), Hospital Universitario Virgen del Rocío/Universidad de Sevilla, Seville, 2CIBER de Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III, Madrid, 3Sección de Neumología, Hospital Puerta del Mar, Cádiz, 4Servicio de Neumología, Hospital Juan Ramón Jiménez, Huelva, 5Servicio de Neumología, Hospital Universitario Reina Sofía, Córdoba, 6Servicio de Neumología, Hospital Universitario San Cecilio, Granada, 7Sección de Neumología, Hospital Infanta Margarita, Cabra, Córdoba, 8Servicio de Neumología, Hospital Torrecárdenas, Almería, 9Servicio de Neumología, Hospital Regional Universitario de Málaga, Málaga, 10Servicio de Neumología, Hospital Universitario Virgen de las Nieves, Granada,Spain Objectives: Clinical practice in chronic obstructive pulmonary disease (COPD) can be influenced by weather variability throughout the year. To explore the hypothesis of seasonal variability in clinical practice, the present study analyzes the results of the 2013–2014 Andalusian COPD audit with regard to changes in clinical practice according to the different seasons.Methods: The Andalusian COPD audit was a pilot clinical project conducted from October 2013 to September 2014 in outpatient respiratory clinics of hospitals in Andalusia, Spain (8provinces with more than 8 million inhabitants) with retrospective data gathering. For the present analysis, astronomical seasons in the Northern Hemisphere were used as reference. Bivariate associations between the different COPD guidelines and the clinical practice changes over the seasons were explored by using binomial multivariate logistic regression analysis with age, sex, Charlson comorbidity index, type of hospital, and COPD severity by forced expiratory volume in 1 second as covariates, and were expressed as odds ratio (OR) with 95% confidence intervals (CIs).Results: The Andalusian COPD audit included 621 clinical records from 9 hospitals. After adjusting for covariates, only inhaler device satisfaction evaluation was found to significantly differ according to the seasons with an increase in winter (OR, 3.460; 95% CI, 1.469–8.151), spring (OR, 4.215; 95% CI, 1.814–9.793), and summer (OR, 3.371; 95% CI, 1.391–8.169) compared to that in autumn. The rest of the observed differences were not significant after adjusting for covariates. However, compliance with evaluating inhaler satisfaction was low.Conclusion: The various aspects of clinical practice for COPD care were found to be quite homogeneous throughout the year for the variables evaluated. Inhaler satisfaction evaluation, however, presented some significant variation during the year. Inhaler device satisfaction should be evaluated during all clinical visits throughout the year for improved COPD management. Keywords: COPD, seasons, clinical practice, quality of care

Jose Luis López-Campos,1,2 María Abad Arranz,1 Carmen Calero Acuña,1,2 Fernando Romero Valero,3 Ruth Ayerbe García,4 Antonio Hidalgo Molina,3 Ricardo I Aguilar Perez-Grovas,4 Francisco García Gil,5 Francisco Casas Maldonado,6 Laura Caballero Ballesteros,5 María Sánchez Palop,6 Dolores Pérez-Tejero,7 Alejandro Segado,7 Jose Calvo Bonachera,8 Bárbara Hernández Sierra,8 Adolfo Doménech,9 Macarena Arroyo Varela,9 Francisco González Vargas,10 Juan J Cruz Rueda10 1Unidad Médico-Quirúrgica de Enfermedades Respiratorias, Instituto de Biomedicina de Sevilla (IBiS), Hospital Universitario Virgen del Rocío/Universidad de Sevilla, Seville, 2Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III, Madrid, 3Hospital Universitario Puerta del Mar, Cádiz, 4Hospital Juan Ramón Jiménez, Huelva, 5Hospital Universitario Reina Sofía, Córdoba, 6Hospital Universitario San Cecilio, Granada, 7Hospital Infanta Margarita, Cabra, Córdoba, 8Hospital Torrecárdenas, Almería, 9Hospital Regional Universitario de Málaga, 10Hospital Universitario Virgen de las Nieves, Granada, Spain Introduction: This study is an analysis of a pilot COPD clinical audit that evaluated adherence to guidelines for patients with COPD in a stable disease phase during a routine visit in specialized secondary care outpatient clinics in order to identify the variables associated with the decision to step-up or step-down pharmacological treatment.Methods: This study was a pilot clinical audit performed at hospital outpatient respiratory clinics in the region of Andalusia, Spain (eight provinces with over eight million inhabitants), in which 20% of centers in the area (catchment population 3,143,086 inhabitants) were invited to participate. Treatment changes were evaluated in terms of the number of prescribed medications and were classified as step-up, step-down, or no change. Three backward stepwise binominal multivariate logistic regression analyses were conducted to evaluate variables associated with stepping up, stepping down, and inhaled corticosteroids discontinuation.Results: The present analysis evaluated 565 clinical records (91%) of the complete audit. Of those records, 366 (64.8%) cases saw no change in pharmacological treatment, while 99patients (17.5%) had an increase in the number of drugs, 55 (9.7%) had a decrease in the number of drugs, and 45 (8.0%) noted a change to other medication for a similar therapeutic scheme. Exacerbations were the main factor in stepping up treatment, as were the symptoms themselves. In contrast, rather than symptoms, doctors used forced expiratory volume in 1second and previous treatment with long-term antibiotics or inhaled corticosteroids as the key determinants to stepping down treatment.Conclusion: The majority of doctors did not change the prescription. When changes were made, a number of related factors were noted. Future trials must evaluate whether these therapeutic changes impact clinically relevant outcomes at follow-up. Keywords: quality of care, outpatient care, treatment strategies, follow-up, respiratory diseases, airway diseases

Jose Luis López-Campos,1,2 Maria Abad Arranz,1 Carmen Calero-Acuña,1,2 Fernando Romero-Valero,3 Ruth Ayerbe-García,4 Antonio Hidalgo-Molina,3 Ricardo I Aguilar-Pérez-Grovas,4 Francisco García-Gil,5 Francisco Casas-Maldonado,6 Laura Caballero-Ballesteros,5 María Sánchez-Palop,6 Dolores Pérez-Tejero,7 Alejandro Segado Soriano,7 Jose Calvo-Bonachera,8 Bárbara Hernández-Sierra,8 Adolfo Doménech,9 Macarena Arroyo-Varela,9 Francisco González-Vargas,10 Juan J Cruz-Rueda10 1Unidad Médico-Quirúrgica de Enfermedades Respiratorias, Instituto de Biomedicina de Sevilla (IBiS), Hospital Universitario Virgen del Rocío/Universidad de Sevilla, Seville, 2CIBER de Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III, Madrid, 3Sección de Neumología, Hospital Puerta del Mar, Cádiz, 4Servicio de Neumología, Hospital Juan Ramón Jiménez, Huelva, 5Servicio de Neumología, Hospital Universitario Reina Sofía, Córdoba, 6Servicio de Neumología, Hospital Universitario San Cecilio, Granada, 7Sección de Neumología, Hospital Infanta Margarita, Cabra, Córdoba, 8Servicio de Neumología, Hospital Torrecárdenas, Almería, 9Servicio de Neumología, Hospital Regional Universitario de Málaga, Málaga, 10Servicio de Neumología, Hospital Universitario Virgen de las Nieves, Granada,Spain Objectives: Clinical practice in chronic obstructive pulmonary disease (COPD) can be influenced by weather variability throughout the year. To explore the hypothesis of seasonal variability in clinical practice, the present study analyzes the results of the 2013–2014 Andalusian COPD audit with regard to changes in clinical practice according to the different seasons.Methods: The Andalusian COPD audit was a pilot clinical project conducted from October 2013 to September 2014 in outpatient respiratory clinics of hospitals in Andalusia, Spain (8provinces with more than 8 million inhabitants) with retrospective data gathering. For the present analysis, astronomical seasons in the Northern Hemisphere were used as reference. Bivariate associations between the different COPD guidelines and the clinical practice changes over the seasons were explored by using binomial multivariate logistic regression analysis with age, sex, Charlson comorbidity index, type of hospital, and COPD severity by forced expiratory volume in 1 second as covariates, and were expressed as odds ratio (OR) with 95% confidence intervals (CIs).Results: The Andalusian COPD audit included 621 clinical records from 9 hospitals. After adjusting for covariates, only inhaler device satisfaction evaluation was found to significantly differ according to the seasons with an increase in winter (OR, 3.460; 95% CI, 1.469–8.151), spring (OR, 4.215; 95% CI, 1.814–9.793), and summer (OR, 3.371; 95% CI, 1.391–8.169) compared to that in autumn. The rest of the observed differences were not significant after adjusting for covariates. However, compliance with evaluating inhaler satisfaction was low.Conclusion: The various aspects of clinical practice for COPD care were found to be quite homogeneous throughout the year for the variables evaluated. Inhaler satisfaction evaluation, however, presented some significant variation during the year. Inhaler device satisfaction should be evaluated during all clinical visits throughout the year for improved COPD management. Keywords: COPD, seasons, clinical practice, quality of care

[Objectives] Previous clinical audits of COPD have provided relevant information about medical intervention in exacerbation admissions. The present study aims to evaluate adherence to current guidelines in COPD through a clinical audit., [Methods] This is a pilot clinical audit performed in hospital outpatient respiratory clinics in Andalusia, Spain (eight provinces with more than 8 million inhabitants), including 9 centers (20% of the public centers in the area) between 2013 and 2014. Cases with an established diagnosis of COPD based on risk factors, clinical symptoms, and a post-bronchodilator FEV1/FVC ratio of less than 0.70 were deemed eligible. The performance of the outpatient clinics was benchmarked against three guidance documents available at the time of the audit. The appropriateness of the performance was categorized as excellent (>80%), good (60−80%), adequate (40−59%), inadequate (20−39%), and highly inadequate (, [Results] During the audit, 621 clinical records were audited. Adherence to the different guidelines presented a considerable variability among the different participating hospitals, with an excellent or good adherence for symptom recording, MRC or CAT use, smoking status evaluation, spirometry, or bronchodilation therapy. The most outstanding areas for improvement were the use of the BODE index, the monitoring of treatments, the determination of alpha1-antitrypsin, the performance of exercise testing, and vaccination recommendations., [Conclusions] The present study reflects the situation of clinical care for COPD patients in specialized secondary care outpatient clinics. Adherence to clinical guidelines shows considerable variability in outpatient clinics managing COPD patients, and some aspects of the clinical care can clearly be improved., This study was financially supported by an unrestricted grant from Laboratorios Menarini, SA (Barcelona, Spain).

Jose Luis López-Campos,1,2 María Abad Arranz,1 Carmen Calero Acuña,1,2 Fernando Romero Valero,3 Ruth Ayerbe García,4 Antonio Hidalgo Molina,3 Ricardo I Aguilar Perez-Grovas,4 Francisco García Gil,5 Francisco Casas Maldonado,6 Laura Caballero Ballesteros,5 María Sánchez Palop,6 Dolores Pérez-Tejero,7 Alejandro Segado,7 Jose Calvo Bonachera,8 Bárbara Hernández Sierra,8 Adolfo Doménech,9 Macarena Arroyo Varela,9 Francisco González Vargas,10 Juan J Cruz Rueda10 1Unidad Médico-Quirúrgica de Enfermedades Respiratorias, Instituto de Biomedicina de Sevilla (IBiS), Hospital Universitario Virgen del Rocío/Universidad de Sevilla, Seville, 2Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III, Madrid, 3Hospital Universitario Puerta del Mar, Cádiz, 4Hospital Juan Ramón Jiménez, Huelva, 5Hospital Universitario Reina Sofía, Córdoba, 6Hospital Universitario San Cecilio, Granada, 7Hospital Infanta Margarita, Cabra, Córdoba, 8Hospital Torrecárdenas, Almería, 9Hospital Regional Universitario de Málaga, 10Hospital Universitario Virgen de las Nieves, Granada, Spain Introduction: This study is an analysis of a pilot COPD clinical audit that evaluated adherence to guidelines for patients with COPD in a stable disease phase during a routine visit in specialized secondary care outpatient clinics in order to identify the variables associated with the decision to step-up or step-down pharmacological treatment.Methods: This study was a pilot clinical audit performed at hospital outpatient respiratory clinics in the region of Andalusia, Spain (eight provinces with over eight million inhabitants), in which 20% of centers in the area (catchment population 3,143,086 inhabitants) were invited to participate. Treatment changes were evaluated in terms of the number of prescribed medications and were classified as step-up, step-down, or no change. Three backward stepwise binominal multivariate logistic regression analyses were conducted to evaluate variables associated with stepping up, stepping down, and inhaled corticosteroids discontinuation.Results: The present analysis evaluated 565 clinical records (91%) of the complete audit. Of those records, 366 (64.8%) cases saw no change in pharmacological treatment, while 99patients (17.5%) had an increase in the number of drugs, 55 (9.7%) had a decrease in the number of drugs, and 45 (8.0%) noted a change to other medication for a similar therapeutic scheme. Exacerbations were the main factor in stepping up treatment, as were the symptoms themselves. In contrast, rather than symptoms, doctors used forced expiratory volume in 1second and previous treatment with long-term antibiotics or inhaled corticosteroids as the key determinants to stepping down treatment.Conclusion: The majority of doctors did not change the prescription. When changes were made, a number of related factors were noted. Future trials must evaluate whether these therapeutic changes impact clinically relevant outcomes at follow-up. Keywords: quality of care, outpatient care, treatment strategies, follow-up, respiratory diseases, airway diseases

Objectives: Previous clinical audits for chronic obstructive pulmonary disease (COPD) have provided valuable information on the clinical care delivered to patients admitted to medical wards because of COPD exacerbations. However, clinical audits of COPD in an outpatient setting are scarce and no methodological guidelines are currently available. Based on our previous experience, herein we describe a clinical audit for COPD patients in specialized outpatient clinics with the overall goal of establishing a potential methodological workflow., Methods: A pilot clinical audit of COPD patients referred to respiratory outpatient clinics in the region of Andalusia, Spain (over 8 million inhabitants), was performed. The audit took place between October 2013 and September 2014, and 10 centers (20% of all public hospitals) were invited to participate. Cases with an established diagnosis of COPD based on risk factors, clinical symptoms, and a post-bronchodilator FEV1/FVC ratio of less than 0.70 were deemed eligible. The usefulness of formally scheduled regular follow-up visits was assessed. Two different databases (resources and clinical database) were constructed. Assessments were planned over a year divided by 4 three-month periods, with the goal of determining seasonal-related changes. Exacerbations and survival served as the main endpoints., Conclusions: This paper describes a methodological framework for conducting a clinical audit of COPD patients in an outpatient setting. Results from such audits can guide health information systems development and implementation in real-world settings., This study was financially supported by an unrestricted grant from Laboratorios Menarini, SA (Barcelona, Spain).